TPLC - Total Product Life Cycle

• Device: orthopedic stereotaxic instrument
• Definition: Stereotaxic guidance during orthopedic surgery procedures. Indicated for Orthopedic joint or spine surgery. Neurological stereotaxic instruments are classified under product code HAW.
• Product Code: OLO
• Regulation Number: 882.4560
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
7D SURGICAL
	SUBSTANTIALLY EQUIVALENT	1
7D SURGICAL INC.
	SUBSTANTIALLY EQUIVALENT	4
ALPHATEC SPINE
	SUBSTANTIALLY EQUIVALENT	1
ALPHATEC SPINE, INC.
	SUBSTANTIALLY EQUIVALENT	4
ASTURA MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
AUGMEDICS LTD
	SUBSTANTIALLY EQUIVALENT	1
AUGMEDICS LTD.
	SUBSTANTIALLY EQUIVALENT	2
BLUE BELT TECHNOLOGIES, INC.
	SUBSTANTIALLY EQUIVALENT	9
BLUE ORTHO
	SUBSTANTIALLY EQUIVALENT	5
BRAINLAB AG
	SUBSTANTIALLY EQUIVALENT	12
CAMBER SPINE TECHNOLOGIES
	SUBSTANTIALLY EQUIVALENT	1
CARBOFIX ORTHOPEDICS LTD.
	SUBSTANTIALLY EQUIVALENT	1
CHOICE SPINE, LP.
	SUBSTANTIALLY EQUIVALENT	1
CHOICESPINE, LLC
	SUBSTANTIALLY EQUIVALENT	2
CLARIANCE, SAS
	SUBSTANTIALLY EQUIVALENT	1
COMERGE AG
	SUBSTANTIALLY EQUIVALENT	1
CORELINK LLC
	SUBSTANTIALLY EQUIVALENT	1
CORELINK, LLC
	SUBSTANTIALLY EQUIVALENT	6
CORIN LTD.
	SUBSTANTIALLY EQUIVALENT	1
CORIN USA
	SUBSTANTIALLY EQUIVALENT	1
CORIN USA LIMITED
	SUBSTANTIALLY EQUIVALENT	1
CTL MEDICAL CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
CUREXO, INC.
	SUBSTANTIALLY EQUIVALENT	3
CURITEVA, INC.
	SUBSTANTIALLY EQUIVALENT	1
DEGEN MEDICAL
	SUBSTANTIALLY EQUIVALENT	2
DEPUY IRELAND UC
	SUBSTANTIALLY EQUIVALENT	3
DEPUY SYNTHES
	SUBSTANTIALLY EQUIVALENT	3
ECENTIAL ROBOTICS
	SUBSTANTIALLY EQUIVALENT	3
ENZTEC LIMITED
	SUBSTANTIALLY EQUIVALENT	1
FIAGON GMBH
	SUBSTANTIALLY EQUIVALENT	1
FUSION ROBOTICS, LLC
	SUBSTANTIALLY EQUIVALENT	2
GENESYS SPINE
	SUBSTANTIALLY EQUIVALENT	1
GLOBUS MEDICAL INC.
	SUBSTANTIALLY EQUIVALENT	4
GLOBUS MEDICAL, INC
	SUBSTANTIALLY EQUIVALENT	1
GLOBUS MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	2
HANGZHOU LANCET ROBOTICS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
ICOTEC AG
	SUBSTANTIALLY EQUIVALENT	1
INNOSYS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
INNOVASIS, INC.
	SUBSTANTIALLY EQUIVALENT	1
INSIGHT MEDICAL SYSTEMS INC.
	SUBSTANTIALLY EQUIVALENT	1
INSIGHT MEDICAL SYSTEMS, INC.
	SUBSTANTIALLY EQUIVALENT	1
INTAI TECHNOLOGY CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
INTEGRITY IMPLANTS INC.
	SUBSTANTIALLY EQUIVALENT	1
INTELLIJOINT SURGICAL INC.
	SUBSTANTIALLY EQUIVALENT	1
IZI MEDICAL PRODUCTS LLC
	SUBSTANTIALLY EQUIVALENT	1
JOIMAX GMBH
	SUBSTANTIALLY EQUIVALENT	1
K2M, INC.
	SUBSTANTIALLY EQUIVALENT	2
KALITEC DIRECT, LLC DOING BUSINESS AS KALITEC MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
KICO KNEE INNOVATION COMPANY PTY LIMITED
	SUBSTANTIALLY EQUIVALENT	2
KICO KNEE INNOVATION COMPANY PTY LTD
	SUBSTANTIALLY EQUIVALENT	1
LIFE SPINE INC.
	SUBSTANTIALLY EQUIVALENT	1
MAKO SURGICAL CORP.
	SUBSTANTIALLY EQUIVALENT	5
MAZOR ROBOTICS LTD.
	SUBSTANTIALLY EQUIVALENT	3
MEDACTA INTERNATIONAL S.A.
	SUBSTANTIALLY EQUIVALENT	4
MEDACTA INTERNATIONAL SA
	SUBSTANTIALLY EQUIVALENT	2
MEDACTA INTERNATIONAL, SA
	SUBSTANTIALLY EQUIVALENT	1
MEDIVIS, INC.
	SUBSTANTIALLY EQUIVALENT	1
MEDOS INTERNATIONAL SARL
	SUBSTANTIALLY EQUIVALENT	1
MEDOS INTERNATIONAL SÀRL
	SUBSTANTIALLY EQUIVALENT	1
MEDOS INTERNATIONAL, SARL
	SUBSTANTIALLY EQUIVALENT	4
MEDTECH S.A.
	SUBSTANTIALLY EQUIVALENT	2
MEDTRONIC
	SUBSTANTIALLY EQUIVALENT	1
MEDTRONIC NAVIGATION
	SUBSTANTIALLY EQUIVALENT	2
MEDTRONIC NAVIGATION, INC.
	SUBSTANTIALLY EQUIVALENT	1
MEDTRONIC POWERED SURGICAL SOLUTIONS
	SUBSTANTIALLY EQUIVALENT	1
MEDTRONIC POWERED SURGICAL SOLUTIONS (MPSS)
	SUBSTANTIALLY EQUIVALENT	1
MEDTRONIC SOFAMOR DANEK INC
	SUBSTANTIALLY EQUIVALENT	1
MEDTRONIC SOFAMOR DANEK USA, INC
	SUBSTANTIALLY EQUIVALENT	1
MEDTRONIC SOFAMOR DANEK USA, INC.
	SUBSTANTIALLY EQUIVALENT	5
MEDTRONIC SOFAMOR DANEK, USA INC
	SUBSTANTIALLY EQUIVALENT	1
MEDTRONIC SOFAMOR DANEK, USA INC.
	SUBSTANTIALLY EQUIVALENT	1
MICROPORT NAVIBOT INTERNATIONAL LLC
	SUBSTANTIALLY EQUIVALENT	1
MIRUS LLC
	SUBSTANTIALLY EQUIVALENT	1
MIRUS, LLC
	SUBSTANTIALLY EQUIVALENT	1
NAVBIT PTY LTD
	SUBSTANTIALLY EQUIVALENT	1
NAVISWISS AG
	SUBSTANTIALLY EQUIVALENT	2
NEXXT SPINE LLC
	SUBSTANTIALLY EQUIVALENT	1
NOVARAD CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
NUVASIVE
	SUBSTANTIALLY EQUIVALENT	1
NUVASIVE, INCORPORATED
	SUBSTANTIALLY EQUIVALENT	3
ONPOINT SURGICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
ORTHALIGN INC
	SUBSTANTIALLY EQUIVALENT	1
ORTHALIGN, INC.
	SUBSTANTIALLY EQUIVALENT	1
ORTHOKEY ITALIA S.R.L.
	SUBSTANTIALLY EQUIVALENT	1
ORTHOPEDIATRICS, CORP.
	SUBSTANTIALLY EQUIVALENT	1
ORTHOSOFT D/B/A ZIMMER CAS
	SUBSTANTIALLY EQUIVALENT	5
ORTHOSOFT INC (D/B/A ZIMMER CAS)
	SUBSTANTIALLY EQUIVALENT	1
ORTHOSOFT INC. (D/B/A ZIMMER CAS)
	SUBSTANTIALLY EQUIVALENT	3
ORTHOSOFT, INC (D/B/A ZIMMER CAS)
	SUBSTANTIALLY EQUIVALENT	2
ORTOMA AB
	SUBSTANTIALLY EQUIVALENT	1
OSSEUS FUSION SYSTEMS
	SUBSTANTIALLY EQUIVALENT	1
PATHKEEPER SURGICAL LTD
	SUBSTANTIALLY EQUIVALENT	1
PIONEER SURGICAL TECHNOLOGY, INC. DBA RTI SURGICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
PIXEE MEDICAL
	SUBSTANTIALLY EQUIVALENT	4
POINT ROBOTICS MEDTECH INC.
	SUBSTANTIALLY EQUIVALENT	3
POLARISAR INC.
	SUBSTANTIALLY EQUIVALENT	1
PRACTICAL NAVIGATION, LLC
	SUBSTANTIALLY EQUIVALENT	1
PRECISION SPINE, INC.
	SUBSTANTIALLY EQUIVALENT	3
PREMIA SPINE, LTD.
	SUBSTANTIALLY EQUIVALENT	1
PROPRIO, INC.
	SUBSTANTIALLY EQUIVALENT	1
PROVIDENCE MEDICAL TECHNOLOGY, INC.
	SUBSTANTIALLY EQUIVALENT	1
REMEX MEDICAL CORP.
	SUBSTANTIALLY EQUIVALENT	3
REMEX MEDICAL CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
REPUBLIC SPINE, LLC
	SUBSTANTIALLY EQUIVALENT	1
SEASPINE ORTHOPEDICS CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
SI-BONE, INC.
	SUBSTANTIALLY EQUIVALENT	2
SILONY MEDICAL GMBH
	SUBSTANTIALLY EQUIVALENT	2
SPINAL ELEMENTS INC
	SUBSTANTIALLY EQUIVALENT	1
SPINE WAVE, INC.
	SUBSTANTIALLY EQUIVALENT	1
SPINEART
	SUBSTANTIALLY EQUIVALENT	1
SPINEART SA
	SUBSTANTIALLY EQUIVALENT	2
SPINECRAFT, LLC
	SUBSTANTIALLY EQUIVALENT	1
SPINEOLOGY INC.
	SUBSTANTIALLY EQUIVALENT	1
STRYKER
	SUBSTANTIALLY EQUIVALENT	1
STRYKER CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
STRYKER GMBH
	SUBSTANTIALLY EQUIVALENT	1
STRYKER LEIBINGER GMBH & CO. KG
	SUBSTANTIALLY EQUIVALENT	6
STRYKER SPINE
	SUBSTANTIALLY EQUIVALENT	1
SURGALIGN SPINE TECHNOLOGIES
	SUBSTANTIALLY EQUIVALENT	2
SURGICAL THEATER, INC.
	SUBSTANTIALLY EQUIVALENT	1
TAIWAN MAIN ORTHOPAEDIC BIOTECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
THINK SURGICAL, INC.
	SUBSTANTIALLY EQUIVALENT	9
TORNIER SAS
	SUBSTANTIALLY EQUIVALENT	1
ULRICH MEDICAL USA
	SUBSTANTIALLY EQUIVALENT	1
ZAVATION MEDICAL PRODUCTS, LLC
	SUBSTANTIALLY EQUIVALENT	1
ZIMMER BIOMET SPINE, INC.
	SUBSTANTIALLY EQUIVALENT	4
ZIMVIE (ZIMMER BIOMET SPINE, INC.)
	SUBSTANTIALLY EQUIVALENT	1
ZIMVIE SPINE (ZIMMER BIOMET SPINE, INC.)
	SUBSTANTIALLY EQUIVALENT	2

MDR Year	MDR Reports	MDR Events
2019	1585	1585
2020	2744	2744
2021	1696	1696
2022	1568	1576
2023	1491	1491
2024	1395	1395

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	1078	1078
Material Integrity Problem	840	840
Mechanical Problem	754	754
Use of Device Problem	653	653
Device Slipped	652	652
Fracture	457	457
Unintended Application Program Shut Down	450	450
Application Program Problem: Parameter Calculation Error	443	443
Incorrect, Inadequate or Imprecise Result or Readings	411	411
Connection Problem	365	365
Detachment of Device or Device Component	360	360
Imprecision	333	333
Computer Software Problem	331	331
Insufficient Information	270	270
Adverse Event Without Identified Device or Use Problem	249	249
Non Reproducible Results	235	235
Physical Resistance/Sticking	213	213
Unintended Movement	212	212
Mechanical Jam	210	210
Material Twisted/Bent	188	188
Device-Device Incompatibility	172	172
Malposition of Device	155	155
Application Program Problem	153	153
Human-Device Interface Problem	150	150
Residue After Decontamination	148	148
Output Problem	145	145
Positioning Problem	126	126
Defective Component	126	126
Display or Visual Feedback Problem	113	113
Solder Joint Fracture	110	110
Material Fragmentation	107	107
Failure to Calibrate	103	103
Mechanics Altered	95	95
Overheating of Device	95	95
Positioning Failure	91	91
Intermittent Continuity	88	88
Premature Separation	80	80
Loose or Intermittent Connection	76	76
Appropriate Term/Code Not Available	72	72
Intermittent Communication Failure	68	68
Device Sensing Problem	67	67
Application Program Freezes, Becomes Nonfunctional	66	66
Noise, Audible	64	64
Improper or Incorrect Procedure or Method	64	64
Failure to Recalibrate	62	62
Material Deformation	60	60
Circuit Failure	59	59
Material Frayed	57	57
Incorrect Measurement	52	52
Complete Loss of Power	49	49

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	5851	5859
No Known Impact Or Consequence To Patient	2068	2068
No Patient Involvement	901	901
No Consequences Or Impact To Patient	634	634
Injury	300	300
Unspecified Tissue Injury	203	203
Spinal Column Injury	152	152
Insufficient Information	150	150
Foreign Body In Patient	147	147
Pain	109	109
Bone Fracture(s)	73	73
Unspecified Infection	51	51
Laceration(s)	47	47
Device Embedded In Tissue or Plaque	41	41
No Code Available	40	40
Tissue Damage	36	36
Nerve Damage	30	30
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	28	28
No Information	28	28
Failure of Implant	27	27
Joint Laxity	26	26
Unspecified Nervous System Problem	26	26
Muscle Weakness	22	22
Cerebrospinal Fluid Leakage	21	21
Hemorrhage/Bleeding	18	18
Inadequate Osseointegration	17	17
Discomfort	16	16
Loss of Range of Motion	14	14
Ambulation Difficulties	13	13
Post Operative Wound Infection	13	13
Deformity/ Disfigurement	11	11
Hip Fracture	10	10
Numbness	10	10
Fibrosis	9	9
Perforation	8	8
Wound Dehiscence	7	7
Spinal Cord Injury	7	7
Paralysis	6	6
Hematoma	6	6
Joint Dislocation	6	6
Complaint, Ill-Defined	6	6
Neuropathy	6	6
Muscle/Tendon Damage	6	6
Damage to Ligament(s)	6	6
Erosion	5	5
Iatrogenic Source	5	5
Fall	5	5
Paresis	5	5
Missing Value Reason	5	5
Rupture	4	4

Recalls
Manufacturer		Recall Class	Date Posted
1	Alphatec Spine, Inc.	II	Nov-08-2022
2	Blue Belt Technologies, Inc	II	Jun-11-2024
3	Blue Belt Technologies, Inc	II	Jan-11-2024
4	Blue Belt Technologies, Inc	II	Oct-05-2023
5	Blue Ortho	II	Oct-23-2020
6	Blue Ortho	II	Feb-11-2020
7	Brainlab AG	II	Mar-28-2023
8	Brainlab AG	II	Aug-29-2020
9	Brainlab AG	II	Aug-13-2020
10	DePuy Orthopaedics, Inc.	II	May-02-2022
11	Exactech, Inc.	II	Jun-30-2023
12	Globus Medical, Inc.	II	Feb-07-2024
13	Globus Medical, Inc.	I	Jan-18-2024
14	Intellijoint Surgical, Inc.	II	Mar-23-2020
15	Intellijoint Surgical, Inc.	II	Aug-08-2019
16	K2M, Inc	II	Oct-07-2019
17	Mako Surgical Corporation	II	Sep-09-2022
18	Mako Surgical Corporation	II	Nov-19-2020
19	Mako Surgical Corporation	II	Jul-31-2020
20	Mako Surgical Corporation	II	Jun-16-2019
21	Mazor Robotics Ltd	II	Sep-16-2024
22	Mazor Robotics Ltd	II	Oct-12-2023
23	Mazor Robotics Ltd	II	Dec-20-2019
24	Medacta Usa Inc	II	Dec-03-2022
25	Medtronic Navigation, Inc.	II	Jan-10-2024
26	Medtronic Navigation, Inc.	II	Jun-09-2020
27	Medtronic Navigation, Inc.	II	Apr-10-2020
28	Medtronic Navigation, Inc.	II	Dec-19-2019
29	Medtronic Sofamor Danek USA, Inc	II	Aug-09-2023
30	NuVasive Inc	III	Feb-03-2023
31	OMNIlife science Inc.	II	Jun-04-2019
32	Orthosoft, Inc. dba Zimmer CAS	II	Mar-03-2022
33	RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)	II	Nov-02-2020
34	RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)	II	Oct-31-2020
35	RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)	II	Oct-27-2020
36	Smith & Nephew, Inc.	II	Apr-01-2020
37	Stryker Orthopaedics	II	May-28-2024
38	Think Surgical, Inc.	II	Mar-20-2024